Etiology of Early Apical Peri-implantitis

Early Apical Peri-implantitis Clinical Trial

— EAP  

Official title:

Etiology of Early Apical Peri-implantitis: A Case-control Study Over a 20-year Period.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523845
• Other study ID #: LPI1
• Status: Completed
• Start date: January 1996
• Est. completion date: December 2016

Study information

• Verified date: May 2018
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A case-control study was performed was performed following the STROBE statement from 1996 to 2016 including patients who were diagnosed with early apical peri-implantitis. Data were collected at the time of implant placement, and once the patients developed signs and symptoms consistent with early apical peri-implantitis, to determine the frequency and etiology of this pathology.

Description:

A case-control study was performed following the STROBE statement (17) at the Oral Surgery Department, Faculty of Medicine and Dentistry (University of Valencia, Spain) from 1996 to 2016, in which patients with early peri-implantitis diagnosed were included (Figure 1). All patients were informed about the study design and procedures. Prior to participating, they were requested to sign an informed consent document. The study design was approved by the Ethical Committee of the University of Valencia (H1478255958653).

Two groups were established: Test group (patients diagnosed with early apical peri-implantitis diagnosed) and Control group (patients whose implants had not developed any inflammatory/infectious process and were osseointegrated).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The following inclusion criteria were applied: patients =18 years old and controlled medical conditions who received treatment with implants. Additionally, for the test group, inclusion criteria were: symptoms and signs suggesting early apical peri-implantitis after implant placement; absence of implant mobility; dull percussion of nonsurmerged implants; presence or absence of radiolucency apically.

Exclusion Criteria:

• for the both groups: implants placed with guided bone regeneration or inadequate follow-up for failing to maintenance visits.

Related Conditions & MeSH terms

• Early Apical Peri-implantitis
• Peri-Implantitis

Intervention

Other:
• Observational intervention to diagnose an early apical peri-implantitis
diagnose an early apical peri-implantitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

References & Publications (4)

Lefever D, Van Assche N, Temmerman A, Teughels W, Quirynen M. Aetiology, microbiology and therapy of periapical lesions around oral implants: a retrospective analysis. J Clin Periodontol. 2013 Mar;40(3):296-302. doi: 10.1111/jcpe.12045. Epub 2012 Dec 27. — View Citation

Peñarrocha-Diago M, Maestre-Ferrín L, Cervera-Ballester J, Peñarrocha-Oltra D. Implant periapical lesion: diagnosis and treatment. Med Oral Patol Oral Cir Bucal. 2012 Nov 1;17(6):e1023-7. — View Citation

Quirynen M, Gijbels F, Jacobs R. An infected jawbone site compromising successful osseointegration. Periodontol 2000. 2003;33:129-44. Review. — View Citation

Zhao D, Wu Y, Xu C, Zhang F. Immediate dental implant placement into infected vs. non-infected sockets: a meta-analysis. Clin Oral Implants Res. 2016 Oct;27(10):1290-1296. doi: 10.1111/clr.12739. Epub 2015 Dec 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	type of surgery	immediate/delayed placement	Intraoperative
Primary	tooth-implant distance	mesial and distal tooth-implant distance measured at the apex	Intraoperative
Primary	Tooth status	apical lesion or endodontic treatment in the tooth being replaced or adjacent tooth endodontically treated	Intraoperative